Experience of using managed entry agreements in the EU: trends and challenges

Abstract

This article provides a comprehensive analysis of the development, implementation, and regulatory evolution of Managed Entry Agreements (MEAs) across European Union member states, highlighting their growing importance as a strategic mechanism for balancing innovation, affordability, and sustainability within healthcare systems. Faced with rising pharmaceutical expenditures, the increasing prevalence of high-cost therapies, and persistent uncertainty surrounding real-world treatment outcomes, European countries have progressively integrated MEAs as a means of sharing clinical and economic risks between manufacturers and payers. The authors outline the conceptual foundations of MEAs, distinguishing between financial-based schemes, outcome-based agreements, and hybrid models that combine elements of both. Particular attention is given to the dynamic legal framework governing MEAs, the variability of national negotiation processes, and the evolving terminology used in international health policy discourse.

The article employs analytical, comparative, and legal-regulatory methods to examine the structure, implementation mechanisms, and policy frameworks of managed entry agreements across EU member states.

The article underscores Italy’s global leadership in designing and implementing outcome-based MEAs, supported by sophisticated national monitoring registries managed by the Italian Medicines Agency (AIFA). These registries enable continuous assessment of therapeutic performance, inform renegotiation of reimbursement conditions, and underpin innovative payment mechanisms such as cost sharing, risk sharing, payment-by-results, and the “success fee” model. The authors also analyse the role of other influential regulators—including NICE in the United Kingdom, IQWiG in Germany, and HAS in France—in shaping country-specific MEA strategies, particularly in oncology, orphan diseases, and advanced therapies. Statistical data from European registries illustrate the financial impact of MEAs, with countries such as Belgium, Italy and France reporting hundreds of millions of euros saved annually through confidential discounts, rebates, and post-marketing adjustments based on observed treatment outcomes.

Despite these achievements, significant systemic challenges persist. The article identifies substantial disparities in the adoption and design of MEAs across EU countries, driven by differences in national healthcare financing models and regulatory capacities.